Back to resultsPerioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
Primary Purpose
Urinary Bladder Cancer, Muscle-invasive
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Enfortumab Vedotin
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder Cancer, Muscle-invasive focused on measuring Muscle-Invasive Bladder Cancer (MIBC), Enfortumab vedotin (EV), Pembrolizumab (MK-3475)
Eligibility Criteria
Inclusion Criteria:
- Have a histologically confirmed diagnosis of urothelial carcinoma/muscle-invasive bladder cancer [MIBC] (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging).
- Clinically nonmetastatic bladder cancer determined by imaging
- Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)
Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria OR be eligible for treatment with cisplatin but decline treatment with cisplatin-based chemotherapy:
- Impaired renal function with measured or calculated creatinine clearance (CrCl) 30 to 59 mL/min (calculated by Cockcroft-Gault method, Modification of Diet of Renal Disease [MDRD] equations, or measured by 24-hour urine collection)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2
- Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric hearing loss
- New York Heart Association (NYHA) Class III heart failure
- Transurethral resection (TUR) of a bladder tumor that is submitted for central pathology assessment and adequate to determine urothelial histology and PD-L1 expression assessment
- ECOG performance status of 0, 1, or 2
- Adequate organ function
- A male participant is eligible to participate if he agrees to use contraception and refrain from donating sperm during the intervention period and for at least 180 days after the last dose of enfortumab vedotin. If the male participants are receiving pembrolizumab only or undergoing surgery only, there are no contraception requirements
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to use a highly effective contraceptive method or be abstinent from heterosexual intercourse (as their preferred and usual lifestyle) during the intervention period and for at least 120 days after the last dose of pembrolizumab and at least 180 days after the last dose of enfortumab vedotin; whichever comes last. A female participant must agree not to donate eggs during this period as well
- A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
Exclusion Criteria:
- Known additional nonurothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions
- Has ≥ N2 or metastatic disease (M1) as identified by imaging
- Received any prior systemic treatment, chemoradiation, and/or radiation therapy for for muscle-invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC)
- Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Received prior systemic anticancer therapy including investigational agents within 3 years prior to randomization
- Received any prior radiotherapy to the bladder
- Received a partial cystectomy of the bladder to remove any non-muscle-invasive bladder cancer (NMIBC) or MIBC
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention
- Ongoing sensory or motor neuropathy Grade 2 or higher
- Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
- Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients
- Severe hypersensitivity (≥ Grade 3) to enfortumab vedotin or any excipient contained in the drug formulation of enfortumab vedotin
- Active keratitis or corneal ulcerations. Participants with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator
- Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed
- Has uncontrolled diabetes
- History of (noninfectious) pneumonitis that required steroids, or current pneumonitis
- Active infection requiring systemic therapy
- Has had an allogeneic tissue/solid organ transplant
Sites / Locations
- University of South Alabama, Mitchell Cancer Institute ( Site 1582)
- CARTI Cancer Center ( Site 1577)
- St. Joseph Heritage Healthcare ( Site 0046)
- Scripps MD Anderson ( Site 0010)
- John Wayne Cancer Institute ( Site 0075)
- University of Colorado Hospital ( Site 0098)
- Georgetown University Medical Center ( Site 0022)Recruiting
- Emory School of Medicine ( Site 0006)
- John H. Stroger Jr. Hospital of Cook County ( Site 1551)Recruiting
- University of Chicago ( Site 0068)
- Parkview Cancer Institute ( Site 0077)Recruiting
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)Recruiting
- Wichita Urology Group ( Site 0059)
- Tulane University ( Site 0088)
- New England Cancer Specialists ( Site 0070)
- Greater Baltimore Medical Center ( Site 0014)
- M Health Fairview Ridges Hospital ( Site 1555)
- Morristown Medical Center ( Site 0015)
- UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
- Northwell Health- Monter Cancer Center ( Site 0083)
- New York University Perlmutter Cancer Center ( Site 0008)
- Icahn School of Medicine at Mount Sinai ( Site 0031)Recruiting
- Cleveland Clinic ( Site 1576)Recruiting
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
- Providence Portland Medical Center [Portland, OR] ( Site 0095)
- MidLantic Urology ( Site 0089)
- Abramson Cancer Center of the University of Pennsylvania ( Site 0074)
- Thomas Jefferson University ( Site 1579)
- Fox Chase Cancer Center ( Site 0055)
- Allegheny General Hospital ( Site 0048)
- Bon Secours St. Francis Health System ( Site 1572)
- Carolina Urologic Research Center ( Site 0062)Recruiting
- Urology Associates [Nashville, TN] ( Site 0053)Recruiting
- Vanderbilt University Medical Center ( Site 0017)
- Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)
- Inova Schar Cancer Institute ( Site 0007)Recruiting
- Charleston Area Medical Center ( Site 0023)
- Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102)Recruiting
- Western Sydney Local Health District ( Site 1259)
- Macquarie University ( Site 1251)
- Cairns Base Hospital ( Site 1257)
- Mater Misericordiae Ltd ( Site 1258)
- Eastern Health ( Site 1255)
- Monash Health ( Site 1260)
- UCL Saint-Luc - Oncologie Medicale ( Site 0357)Recruiting
- CHU UCL Namur Site de Godinne ( Site 0354)
- AZ Maria Middelares Gent ( Site 0353)Recruiting
- UZ Leuven ( Site 0361)
- AZ Sint-Jan Brugge ( Site 0352)Recruiting
- AZ Delta vzw-Oncology ( Site 0362)Recruiting
- Tom Baker Cancer Centre ( Site 0100)Recruiting
- BC Cancer Vancouver-Clinical Trials Unit ( Site 0121)Recruiting
- Silverado Resarch Inc. ( Site 0111)
- Moncton Hospital - Horizon Health Network ( Site 0112)Recruiting
- Sunnybrook Research Institute ( Site 0110)Recruiting
- Princess Margaret Cancer Centre ( Site 0107)
- CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)Recruiting
- CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)Recruiting
- Jewish General Hospital ( Site 0120)Recruiting
- McGill University Health Centre ( Site 0123)Recruiting
- CIUSSS de l'Estrie-CHUS ( Site 0106)Recruiting
- Fundación Cardiovascular de Colombia ( Site 2004)Recruiting
- Herlev og Gentofte Hospital. ( Site 0412)Recruiting
- Rigshospitalet University Hospital ( Site 0411)Recruiting
- Aarhus University Hospital Skejby ( Site 0418)Recruiting
- Odense Universitetshospital ( Site 0413)Recruiting
- Hopital de la Timone ( Site 0489)Recruiting
- Centre Francois Baclesse ( Site 0459)Recruiting
- Centre Georges Francois Leclerc ( Site 0488)
- CHU Jean Minjoz ( Site 0455)
- Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)Recruiting
- CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
- Institut Claudius Regaud IUCT Oncopole ( Site 0486)
- C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)
- CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)Recruiting
- CHU Hotel Dieu Nantes ( Site 0458)Recruiting
- Hopital Belle Isle ( Site 0452)Recruiting
- C.H.U. Lyon Sud ( Site 0466)
- Institut Gustave Roussy ( Site 0487)
- CHU Cochin ( Site 0475)
- Hopital Europeen Georges Pompidou ( Site 0476)
- Hopital Bichat du Paris ( Site 0462)Recruiting
- Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)Recruiting
- Universitaetsklinikum Erlangen ( Site 0546)Recruiting
- Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)Recruiting
- Universitaetsklinikum Wuerzburg ( Site 0547)Recruiting
- Universitaetsklinikum Bonn ( Site 0550)Recruiting
- Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)Recruiting
- Universitaetsklinikum Carl Gustav Carus ( Site 0532)
- SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533)Recruiting
- Vivantes Klinikum am Urban ( Site 0529)Recruiting
- Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528)Recruiting
- SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)Recruiting
- Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)Recruiting
- Debreceni Egyetem Klinikai Kozpont ( Site 1006)Recruiting
- Petz Aladar Megyei Oktato Korhaz ( Site 1012)
- Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
- Tallaght University Hospital ( Site 0734)Recruiting
- University Hospital Waterford ( Site 0747)Recruiting
- Ha Emek Medical Center ( Site 0843)
- Soroka Medical Center ( Site 0849)Recruiting
- Rambam Health Care Campus-Oncology Division ( Site 0845)Recruiting
- Shaare Zedek Medical Center ( Site 0842)Recruiting
- Hadassah Ein Kerem Medical Center ( Site 0841)Recruiting
- Meir Medical Center ( Site 0846)Recruiting
- Rabin Medical Center ( Site 0847)Recruiting
- Sheba Medical Center ( Site 0844)Recruiting
- Sourasky Medical Center ( Site 0850)Recruiting
- Yitzhak Shamir Medical Center ( Site 0848)Recruiting
- Policlinico Gemelli di Roma ( Site 0558)Recruiting
- Ospedale San Raffaele-Oncologia Medica ( Site 0561)Recruiting
- Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563)Recruiting
- AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)
- Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565)Recruiting
- A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)Recruiting
- Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)Recruiting
- Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)Recruiting
- Fondazione Salvatore Maugeri IRCCS ( Site 0554)
- Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564)Recruiting
- National Cancer Center Hospital East ( Site 2305)Recruiting
- St. Marianna University Hospital ( Site 2321)Recruiting
- Kitasato University Hospital ( Site 2306)Recruiting
- Yokosukakyosai ( Site 2307)Recruiting
- Tohoku University Hospital ( Site 2301)Recruiting
- Nagano Municipal Hospital ( Site 2309)Recruiting
- Nara Medical University Hospital ( Site 2312)Recruiting
- Osaka Rosai Hospital ( Site 2320)Recruiting
- Saitama Prefectural Cancer Center ( Site 2319)Recruiting
- Dokkyo Medical University Saitama Medical Center ( Site 2304)Recruiting
- Hamamatsu University Hospital ( Site 2311)Recruiting
- Tokyo Medical and Dental University Hospital ( Site 2303)Recruiting
- Toranomon Hospital ( Site 2322)Recruiting
- Toyama University Hospital ( Site 2308)Recruiting
- Gifu University Hospital ( Site 2310)Recruiting
- Kagoshima University Hospital ( Site 2317)Recruiting
- Nagasaki University Hospital ( Site 2315)Recruiting
- National Cancer Center ( Site 1354)Recruiting
- Seoul National University Bundang Hospital ( Site 1356)Recruiting
- Asan Medical Center ( Site 1355)
- Kyungpook National University Chilgok Hospital-Urology ( Site 1357)Recruiting
- Korea University Anam Hospital ( Site 1351)Recruiting
- Seoul National University Hospital ( Site 1352)Recruiting
- Samsung Medical Center ( Site 1353)Recruiting
- University Malaya Medical Centre ( Site 1702)Recruiting
- Hospital Pulau Pinang ( Site 1703)Recruiting
- Sarawak General Hospital ( Site 1701)Recruiting
- Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
- Centro Estatal de Cancerologia de Chihuahua ( Site 0254)
- Instituto Nacional de Cancerologia. ( Site 0256)
- Centro de Tratamiento de Cancer ( Site 0266)
- Hospital Angeles Roma ( Site 0262)
- THE MEDICAL CITY ILOILO ( Site 1756)Recruiting
- The Medical City ( Site 1752)Recruiting
- St. Luke s Medical Center ( Site 1751)Recruiting
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)Recruiting
- Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)Recruiting
- Szpital Wojewodzki ( Site 1062)Recruiting
- Europejskie Centrum Zdrowia Otwock ( Site 1058)
- Luxmed Onkologia sp. z o. o. ( Site 1051)Recruiting
- Bialostockie Centrum Onkologii ( Site 1072)Recruiting
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)Recruiting
- Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)
- Clinical Research Center Medic-R ( Site 1073)Recruiting
- Clinic of Bashkortostan State Medical University ( Site 0873)
- Ivanovo Regional Oncology Dispensary ( Site 0852)
- Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
- Kursk Regional Clinical Oncology Dispensary ( Site 0854)
- Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)
- First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)
- Central Clinical Hospital with outpatient Clinic ( Site 0856)
- Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
- Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
- Omsk Clinical Oncology Dispensary ( Site 0865)
- Leningrad Regional Oncology Center ( Site 0868)
- First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)
- National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)
- Clinical Hospital Saint Luka ( Site 0867)
- Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
- Sverdlovsk Regional Oncology Hospital ( Site 0874)
- Medical Sanitary Unit Neftyannik ( Site 0888)
- National University Hospital ( Site 1802)Recruiting
- Tan Tock Seng Hospital ( Site 1804)Recruiting
- Steve Biko Academic Hospital-Medical Oncology ( Site 1601)Recruiting
- Groote Schuur Hospital ( Site 1602)Recruiting
- Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)Recruiting
- Hospital Clinic i Provincial ( Site 0674)Recruiting
- Hospital San Pedro de Alcantara ( Site 0697)Recruiting
- Institut Català d'Oncologia (ICO) - Girona ( Site 0700)Recruiting
- Hospital Universitario Quiron Madrid ( Site 0694)
- Instituto Valenciano de Oncologia - IVO ( Site 0679)Recruiting
- Hospital del Mar ( Site 0698)Recruiting
- Hospital Universitario Ramon y Cajal ( Site 0691)Recruiting
- Hospital Universitario San Carlos ( Site 0678)Recruiting
- Hospital Universitario la Paz ( Site 0690)Recruiting
- Hospital de Nuestra Senora de Valme ( Site 0693)Recruiting
- Laenssjukhuset Ryhov ( Site 1215)Recruiting
- Karolinska Universitetssjukhuset Solna ( Site 1212)Recruiting
- Akademiska Sjukhuset ( Site 1211)Recruiting
- Cancercentrum ( Site 1214)
- Onkologiska kliniken ( Site 1217)Recruiting
- Ramathibodi Hospital. ( Site 1451)Recruiting
- Faculty of Medicine Siriraj Hospital ( Site 1452)Recruiting
- Maharaj Nakorn Chiangmai Hospital ( Site 1453)Recruiting
- Srinagarind Hospital ( Site 1454)Recruiting
- Hacettepe Universitesi Tıp Fakultesi ( Site 0931)Recruiting
- Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)Recruiting
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)Recruiting
- Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)Recruiting
- Sakarya Universitesi Tip Fakultesi ( Site 0933)Recruiting
- Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)Recruiting
- Cherkasy Regional Oncology Dispensary ( Site 0959)
- MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
- Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
- Regional Oncology Center of Kharkiv ( Site 0958)Recruiting
- Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
- Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)
- Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
- National Cancer Institute of the MoH of Ukraine ( Site 0962)
- Lviv Regional Clinical Hospital ( Site 0955)
- Lviv State Regional Oncological Center ( Site 0967)
- Zhytomyr Regional Oncology Center ( Site 0971)
- Kyiv City Clinical Oncology Center ( Site 0960)
- Kent and Canterbury Hospital ( Site 0733)
- The James Cook University Hospital ( Site 0730)Recruiting
- Lister Hospital ( Site 0739)
- Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)Recruiting
- The Royal Marsden Foundation Trust ( Site 0726)Recruiting
- Imperial College Healthcare NHS Trust ( Site 0745)Recruiting
- Western General Hospital ( Site 0749)Recruiting
- Walsall Manor Hospital-Oncology ( Site 0743)
- Royal Cornwall Hospital ( Site 0727)
- Clatterbridge Oncology Centre ( Site 0731)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Arm A: Pembrolizumab + Surgery
Arm B: Surgery alone
Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
Arm Description
Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
Participants receive standard of care surgery alone.
Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Outcomes
Primary Outcome Measures
Event-Free Survival (EFS) between Arm C and Arm B
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Secondary Outcome Measures
EFS between Arm A and Arm B
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Overall Survival (OS) between Arm C and Arm B
OS is defined as the time from randomization to death due to any cause.
OS between Arm A and Arm B
OS is defined as the time from randomization to death due to any cause.
Pathologic Complete Response (pCR) Rate between Arm C and Arm B
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally.
pCR Rate between Arm A and Arm B
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally.
Disease-Free Survival (DFS)
DFS is defined as the time from first post-surgery baseline scan until:
local or distant recurrence as assessed by imaging and/or biopsy
Death due to any cause
Pathologic Downstaging (pDS) Rate between Arm A and Arm B
Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of <pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC and PLND.
pDS Rate between Arm C and Arm B
Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of <pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC and PLND.
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Number of Participants Experiencing Perioperative Complications
The number of participants who experience perioperative complications will be presented.
Full Information
NCT ID
NCT03924895
First Posted
April 22, 2019
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Seagen Inc., Astellas Pharma Global Development, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03924895
Brief Title
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
Official Title
A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
December 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Seagen Inc., Astellas Pharma Global Development, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).
The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.
With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.
With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Cancer, Muscle-invasive
Keywords
Muscle-Invasive Bladder Cancer (MIBC), Enfortumab vedotin (EV), Pembrolizumab (MK-3475)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
857 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Pembrolizumab + Surgery
Arm Type
Experimental
Arm Description
Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
Arm Title
Arm B: Surgery alone
Arm Type
Active Comparator
Arm Description
Participants receive standard of care surgery alone.
Arm Title
Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
Arm Type
Experimental
Arm Description
Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
Intervention Type
Procedure
Intervention Name(s)
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Intervention Description
Surgical RC+PLND will be done in accordance with the American Urological Association (AUA)/American Society of Clinical Oncology (ASCO)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO) guidelines.
Intervention Type
Drug
Intervention Name(s)
Enfortumab Vedotin
Other Intervention Name(s)
Padcev, ASG-22CE, ASG-22ME
Intervention Description
Enfortumab vedotin 1.25 mg/kg by intravenous (IV) infusion, given on Days 1 and 8 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Event-Free Survival (EFS) between Arm C and Arm B
Description
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Time Frame
Up to approximately 7.7 years
Secondary Outcome Measure Information:
Title
EFS between Arm A and Arm B
Description
EFS is defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy, or death due to any cause.
Time Frame
Up to approximately 7.7 years
Title
Overall Survival (OS) between Arm C and Arm B
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 8.4 years
Title
OS between Arm A and Arm B
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 8.4 years
Title
Pathologic Complete Response (pCR) Rate between Arm C and Arm B
Description
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally.
Time Frame
Up to approximately 5.7 years
Title
pCR Rate between Arm A and Arm B
Description
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally.
Time Frame
Up to approximately 5.7 years
Title
Disease-Free Survival (DFS)
Description
DFS is defined as the time from first post-surgery baseline scan until:
local or distant recurrence as assessed by imaging and/or biopsy
Death due to any cause
Time Frame
Up to approximately 7.7 years
Title
Pathologic Downstaging (pDS) Rate between Arm A and Arm B
Description
Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of <pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC and PLND.
Time Frame
Up to approximately 5.7 years
Title
pDS Rate between Arm C and Arm B
Description
Pathologic downstaging rate is defined as the percentage of participants having pDS. pDS is defined as participants with a tumor classification of <pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC and PLND.
Time Frame
Up to approximately 5.7 years
Title
Number of Participants Experiencing Adverse Events (AEs)
Description
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Time Frame
Up to approximately 8.4 years
Title
Number of Participants Discontinuing Study Drug Due to Adverse Events (AEs)
Description
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Time Frame
Up to approximately 1 year
Title
Number of Participants Experiencing Perioperative Complications
Description
The number of participants who experience perioperative complications will be presented.
Time Frame
Up to approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a histologically confirmed diagnosis of urothelial carcinoma/muscle-invasive bladder cancer [MIBC] (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging).
Clinically nonmetastatic bladder cancer determined by imaging
Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)
Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria OR be eligible for treatment with cisplatin but decline treatment with cisplatin-based chemotherapy:
Impaired renal function with measured or calculated creatinine clearance (CrCl) 30 to 59 mL/min (calculated by Cockcroft-Gault method, Modification of Diet of Renal Disease [MDRD] equations, or measured by 24-hour urine collection)
Eastern Cooperative Oncology Group (ECOG) Performance Status 2
Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric hearing loss
New York Heart Association (NYHA) Class III heart failure
Transurethral resection (TUR) of a bladder tumor that is submitted for central pathology assessment and adequate to determine urothelial histology and PD-L1 expression assessment
ECOG performance status of 0, 1, or 2
Adequate organ function
A male participant is eligible to participate if he agrees to use contraception and refrain from donating sperm during the intervention period and for at least 180 days after the last dose of enfortumab vedotin. If the male participants are receiving pembrolizumab only or undergoing surgery only, there are no contraception requirements
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to use a highly effective contraceptive method or be abstinent from heterosexual intercourse (as their preferred and usual lifestyle) during the intervention period and for at least 120 days after the last dose of pembrolizumab and at least 180 days after the last dose of enfortumab vedotin; whichever comes last. A female participant must agree not to donate eggs during this period as well
A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
Exclusion Criteria:
Known additional nonurothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions
Has ≥ N2 or metastatic disease (M1) as identified by imaging
Received any prior systemic treatment, chemoradiation, and/or radiation therapy for for muscle-invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC)
Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Received prior systemic anticancer therapy including investigational agents within 3 years prior to randomization
Received any prior radiotherapy to the bladder
Received a partial cystectomy of the bladder to remove any non-muscle-invasive bladder cancer (NMIBC) or MIBC
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention
Ongoing sensory or motor neuropathy Grade 2 or higher
Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients
Severe hypersensitivity (≥ Grade 3) to enfortumab vedotin or any excipient contained in the drug formulation of enfortumab vedotin
Active keratitis or corneal ulcerations. Participants with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator
Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed
Has uncontrolled diabetes
History of (noninfectious) pneumonitis that required steroids, or current pneumonitis
Active infection requiring systemic therapy
Has had an allogeneic tissue/solid organ transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama, Mitchell Cancer Institute ( Site 1582)
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Completed
Facility Name
CARTI Cancer Center ( Site 1577)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. Joseph Heritage Healthcare ( Site 0046)
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Completed
Facility Name
Scripps MD Anderson ( Site 0010)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Completed
Facility Name
John Wayne Cancer Institute ( Site 0075)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Completed
Facility Name
University of Colorado Hospital ( Site 0098)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
Georgetown University Medical Center ( Site 0022)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
202-444-2198
Facility Name
Emory School of Medicine ( Site 0006)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Completed
Facility Name
John H. Stroger Jr. Hospital of Cook County ( Site 1551)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
312-864-6000
Facility Name
University of Chicago ( Site 0068)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Parkview Cancer Institute ( Site 0077)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
833-724-8326
Facility Name
Indiana University Melvin and Bren Simon Comprehensive Cancer Center ( Site 0004)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
317-274-7477
Facility Name
Wichita Urology Group ( Site 0059)
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Completed
Facility Name
Tulane University ( Site 0088)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New England Cancer Specialists ( Site 0070)
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Greater Baltimore Medical Center ( Site 0014)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
M Health Fairview Ridges Hospital ( Site 1555)
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Individual Site Status
Completed
Facility Name
Morristown Medical Center ( Site 0015)
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwell Health- Monter Cancer Center ( Site 0083)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Completed
Facility Name
New York University Perlmutter Cancer Center ( Site 0008)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 0031)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-659-5452
Facility Name
Cleveland Clinic ( Site 1576)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
866-223-8100
Facility Name
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Individual Site Status
Completed
Facility Name
Providence Portland Medical Center [Portland, OR] ( Site 0095)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Completed
Facility Name
MidLantic Urology ( Site 0089)
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Completed
Facility Name
Abramson Cancer Center of the University of Pennsylvania ( Site 0074)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Completed
Facility Name
Thomas Jefferson University ( Site 1579)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Fox Chase Cancer Center ( Site 0055)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Completed
Facility Name
Allegheny General Hospital ( Site 0048)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Completed
Facility Name
Bon Secours St. Francis Health System ( Site 1572)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Carolina Urologic Research Center ( Site 0062)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8434491010257
Facility Name
Urology Associates [Nashville, TN] ( Site 0053)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
615-250-9268
Facility Name
Vanderbilt University Medical Center ( Site 0017)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Completed
Facility Name
Inova Schar Cancer Institute ( Site 0007)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
571-472-0623
Facility Name
Charleston Area Medical Center ( Site 0023)
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102)
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+5491157654803
Facility Name
Western Sydney Local Health District ( Site 1259)
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Completed
Facility Name
Macquarie University ( Site 1251)
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Completed
Facility Name
Cairns Base Hospital ( Site 1257)
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Individual Site Status
Completed
Facility Name
Mater Misericordiae Ltd ( Site 1258)
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Completed
Facility Name
Eastern Health ( Site 1255)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Completed
Facility Name
Monash Health ( Site 1260)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Completed
Facility Name
UCL Saint-Luc - Oncologie Medicale ( Site 0357)
City
Bruxelles
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3227649457
Facility Name
CHU UCL Namur Site de Godinne ( Site 0354)
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Completed
Facility Name
AZ Maria Middelares Gent ( Site 0353)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3292469522
Facility Name
UZ Leuven ( Site 0361)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Completed
Facility Name
AZ Sint-Jan Brugge ( Site 0352)
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3250452806
Facility Name
AZ Delta vzw-Oncology ( Site 0362)
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3251237511
Facility Name
Tom Baker Cancer Centre ( Site 0100)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4034762543
Facility Name
BC Cancer Vancouver-Clinical Trials Unit ( Site 0121)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
6048776000
Facility Name
Silverado Resarch Inc. ( Site 0111)
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 2C1
Country
Canada
Individual Site Status
Completed
Facility Name
Moncton Hospital - Horizon Health Network ( Site 0112)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5068575669
Facility Name
Sunnybrook Research Institute ( Site 0110)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4164804928
Facility Name
Princess Margaret Cancer Centre ( Site 0107)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4185411000
Facility Name
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5142523400x5766
Facility Name
Jewish General Hospital ( Site 0120)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5143408222
Facility Name
McGill University Health Centre ( Site 0123)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5149341934 x35800
Facility Name
CIUSSS de l'Estrie-CHUS ( Site 0106)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
819346111012827
Facility Name
Fundación Cardiovascular de Colombia ( Site 2004)
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3107814776
Facility Name
Herlev og Gentofte Hospital. ( Site 0412)
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+45 38683868
Facility Name
Rigshospitalet University Hospital ( Site 0411)
City
Kobenhavn
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+45 35453545
Facility Name
Aarhus University Hospital Skejby ( Site 0418)
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
78450000
Facility Name
Odense Universitetshospital ( Site 0413)
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4524998173
Facility Name
Hopital de la Timone ( Site 0489)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3391387658
Facility Name
Centre Francois Baclesse ( Site 0459)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14075
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33231455002
Facility Name
Centre Georges Francois Leclerc ( Site 0488)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Jean Minjoz ( Site 0455)
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)
City
Nimes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33466683301
Facility Name
CHU de Bordeaux- Hopital Saint Andre ( Site 0456)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0486)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Individual Site Status
Active, not recruiting
Facility Name
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35033
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33467332309
Facility Name
CHU Hotel Dieu Nantes ( Site 0458)
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33244765930
Facility Name
Hopital Belle Isle ( Site 0452)
City
Vantoux
State/Province
Moselle
ZIP/Postal Code
57070
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+0357841650
Facility Name
C.H.U. Lyon Sud ( Site 0466)
City
Pierre Benite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Gustave Roussy ( Site 0487)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Cochin ( Site 0475)
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Europeen Georges Pompidou ( Site 0476)
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Bichat du Paris ( Site 0462)
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33158412754
Facility Name
Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4970712987235
Facility Name
Universitaetsklinikum Erlangen ( Site 0546)
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91058
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4991318223122
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+498944000
Facility Name
Universitaetsklinikum Wuerzburg ( Site 0547)
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4993120132091
Facility Name
Universitaetsklinikum Bonn ( Site 0550)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4922828714184
Facility Name
Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493916715034
Facility Name
Universitaetsklinikum Carl Gustav Carus ( Site 0532)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Completed
Facility Name
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533)
City
Gera
State/Province
Thuringen
ZIP/Postal Code
07548
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+493658287758
Facility Name
Vivantes Klinikum am Urban ( Site 0529)
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4930130226301
Facility Name
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49 15222815585
Facility Name
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3662545405
Facility Name
Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36703815172
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 1006)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3652255585
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 1012)
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Individual Site Status
Completed
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Completed
Facility Name
Tallaght University Hospital ( Site 0734)
City
Dublin
ZIP/Postal Code
D24 NR0A
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+35314144259
Facility Name
University Hospital Waterford ( Site 0747)
City
Waterford
ZIP/Postal Code
X91ER8E
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+35351848934
Facility Name
Ha Emek Medical Center ( Site 0843)
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Individual Site Status
Completed
Facility Name
Soroka Medical Center ( Site 0849)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972523514527
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 0845)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97247776750
Facility Name
Shaare Zedek Medical Center ( Site 0842)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97226666331
Facility Name
Hadassah Ein Kerem Medical Center ( Site 0841)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972505172315
Facility Name
Meir Medical Center ( Site 0846)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97297471606
Facility Name
Rabin Medical Center ( Site 0847)
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97239378074
Facility Name
Sheba Medical Center ( Site 0844)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97235302191
Facility Name
Sourasky Medical Center ( Site 0850)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97236973413
Facility Name
Yitzhak Shamir Medical Center ( Site 0848)
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97289779715
Facility Name
Policlinico Gemelli di Roma ( Site 0558)
City
Roma
State/Province
Abruzzo
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390630154953
Facility Name
Ospedale San Raffaele-Oncologia Medica ( Site 0561)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390226435668
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563)
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390119026993
Facility Name
AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565)
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390575255446
Facility Name
A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390953781518
Facility Name
Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223902402
Facility Name
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39815903637
Facility Name
Fondazione Salvatore Maugeri IRCCS ( Site 0554)
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564)
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
390744205410
Facility Name
National Cancer Center Hospital East ( Site 2305)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81471331111
Facility Name
St. Marianna University Hospital ( Site 2321)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81449778111
Facility Name
Kitasato University Hospital ( Site 2306)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81427788111
Facility Name
Yokosukakyosai ( Site 2307)
City
Yokosuka
State/Province
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81468222710
Facility Name
Tohoku University Hospital ( Site 2301)
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-22-717-7278
Facility Name
Nagano Municipal Hospital ( Site 2309)
City
Tomitake
State/Province
Nagano
ZIP/Postal Code
381-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81262951199
Facility Name
Nara Medical University Hospital ( Site 2312)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81744223051
Facility Name
Osaka Rosai Hospital ( Site 2320)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81722523561
Facility Name
Saitama Prefectural Cancer Center ( Site 2319)
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81487221111
Facility Name
Dokkyo Medical University Saitama Medical Center ( Site 2304)
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81489651111
Facility Name
Hamamatsu University Hospital ( Site 2311)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81534352306
Facility Name
Tokyo Medical and Dental University Hospital ( Site 2303)
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81358035295
Facility Name
Toranomon Hospital ( Site 2322)
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81335881111
Facility Name
Toyama University Hospital ( Site 2308)
City
Toyoma
State/Province
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81764347372
Facility Name
Gifu University Hospital ( Site 2310)
City
Gifu
ZIP/Postal Code
501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-58-230-6338
Facility Name
Kagoshima University Hospital ( Site 2317)
City
Kagoshima
ZIP/Postal Code
8900053
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-99-275-5553
Facility Name
Nagasaki University Hospital ( Site 2315)
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81958197200
Facility Name
National Cancer Center ( Site 1354)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82319201678
Facility Name
Seoul National University Bundang Hospital ( Site 1356)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82317877351
Facility Name
Asan Medical Center ( Site 1355)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Kyungpook National University Chilgok Hospital-Urology ( Site 1357)
City
Deagu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-53-200-3027
Facility Name
Korea University Anam Hospital ( Site 1351)
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8229206610
Facility Name
Seoul National University Hospital ( Site 1352)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82220720361
Facility Name
Samsung Medical Center ( Site 1353)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82234103557
Facility Name
University Malaya Medical Centre ( Site 1702)
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+60379492120
Facility Name
Hospital Pulau Pinang ( Site 1703)
City
Georgetown
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+604 222 5711
Facility Name
Sarawak General Hospital ( Site 1701)
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6082-276666
Facility Name
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
66269
Country
Mexico
Individual Site Status
Completed
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)
City
Aguascalientes
ZIP/Postal Code
20010
Country
Mexico
Individual Site Status
Completed
Facility Name
Centro Estatal de Cancerologia de Chihuahua ( Site 0254)
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Completed
Facility Name
Instituto Nacional de Cancerologia. ( Site 0256)
City
Ciudad de Mexico
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Completed
Facility Name
Centro de Tratamiento de Cancer ( Site 0266)
City
Metepec
ZIP/Postal Code
52140
Country
Mexico
Individual Site Status
Completed
Facility Name
Hospital Angeles Roma ( Site 0262)
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Completed
Facility Name
THE MEDICAL CITY ILOILO ( Site 1756)
City
Iloilo City
State/Province
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
09274761729
Facility Name
The Medical City ( Site 1752)
City
Pasig City
State/Province
National Capital Region
ZIP/Postal Code
1605
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639178448605
Facility Name
St. Luke s Medical Center ( Site 1751)
City
Quezon City
State/Province
National Capital Region
ZIP/Postal Code
1112
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639285030641
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48601143281
Facility Name
Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48605680944
Facility Name
Szpital Wojewodzki ( Site 1062)
City
Tarnow
State/Province
Malopolskie
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48728355694
Facility Name
Europejskie Centrum Zdrowia Otwock ( Site 1058)
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Completed
Facility Name
Luxmed Onkologia sp. z o. o. ( Site 1051)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48224308700
Facility Name
Bialostockie Centrum Onkologii ( Site 1072)
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-027
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48733100715
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)
City
Slupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48598460705
Facility Name
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)
City
Bielsko-Biala
State/Province
Slaskie
ZIP/Postal Code
43-300
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Center Medic-R ( Site 1073)
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-848
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
48 508 109 295
Facility Name
Clinic of Bashkortostan State Medical University ( Site 0873)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450081
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Ivanovo Regional Oncology Dispensary ( Site 0852)
City
Ivanovo
State/Province
Ivanovskaya Oblast
ZIP/Postal Code
153040
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660133
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Kursk Regional Clinical Oncology Dispensary ( Site 0854)
City
Kursk
State/Province
Kurskaya Oblast
ZIP/Postal Code
305524
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Central Clinical Hospital with outpatient Clinic ( Site 0856)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Bayandin Murmansk Regional Clinical Hospital ( Site 0859)
City
Murmansk
State/Province
Murmanskaya Oblast
ZIP/Postal Code
183057
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)
City
Nizhny Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603074
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Omsk Clinical Oncology Dispensary ( Site 0865)
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Leningrad Regional Oncology Center ( Site 0868)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
188663
Country
Russian Federation
Individual Site Status
Completed
Facility Name
First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Completed
Facility Name
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Clinical Hospital Saint Luka ( Site 0867)
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194044
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)
City
Saratov
State/Province
Saratovskaya Oblast
ZIP/Postal Code
410012
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Sverdlovsk Regional Oncology Hospital ( Site 0874)
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Medical Sanitary Unit Neftyannik ( Site 0888)
City
Tyumen
State/Province
Tyumenskaya Oblast
ZIP/Postal Code
625000
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
National University Hospital ( Site 1802)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6567795555
Facility Name
Tan Tock Seng Hospital ( Site 1804)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
398442
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6563596554
Facility Name
Steve Biko Academic Hospital-Medical Oncology ( Site 1601)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27123541771
Facility Name
Groote Schuur Hospital ( Site 1602)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27 214485707
Facility Name
Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+349334978925
Facility Name
Hospital Clinic i Provincial ( Site 0674)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932275400
Facility Name
Hospital San Pedro de Alcantara ( Site 0697)
City
Caceres
State/Province
Extremadura
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34927256200
Facility Name
Institut Català d'Oncologia (ICO) - Girona ( Site 0700)
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+349722258284028
Facility Name
Hospital Universitario Quiron Madrid ( Site 0694)
City
Pozuelo de Alarcon
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Completed
Facility Name
Instituto Valenciano de Oncologia - IVO ( Site 0679)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34961114605
Facility Name
Hospital del Mar ( Site 0698)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932483139
Facility Name
Hospital Universitario Ramon y Cajal ( Site 0691)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913368263
Facility Name
Hospital Universitario San Carlos ( Site 0678)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913303000ext7554
Facility Name
Hospital Universitario la Paz ( Site 0690)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34912071138
Facility Name
Hospital de Nuestra Senora de Valme ( Site 0693)
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34955015000
Facility Name
Laenssjukhuset Ryhov ( Site 1215)
City
Jonkoping
State/Province
Jonkopings Lan
ZIP/Postal Code
551 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46102410000
Facility Name
Karolinska Universitetssjukhuset Solna ( Site 1212)
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46851770000
Facility Name
Akademiska Sjukhuset ( Site 1211)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+46186110000
Facility Name
Cancercentrum ( Site 1214)
City
Umea
State/Province
Vasterbottens Lan
ZIP/Postal Code
901 85
Country
Sweden
Individual Site Status
Completed
Facility Name
Onkologiska kliniken ( Site 1217)
City
Goteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
46313421000
Facility Name
Ramathibodi Hospital. ( Site 1451)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6622011671
Facility Name
Faculty of Medicine Siriraj Hospital ( Site 1452)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6624194488
Facility Name
Maharaj Nakorn Chiangmai Hospital ( Site 1453)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+66539455324
Facility Name
Srinagarind Hospital ( Site 1454)
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6643363225
Facility Name
Hacettepe Universitesi Tıp Fakultesi ( Site 0931)
City
Ankara
State/Province
Adana
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903123055000
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905324167355
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905323430723
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905333832234
Facility Name
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+903322236000
Facility Name
Sakarya Universitesi Tip Fakultesi ( Site 0933)
City
Sakarya
ZIP/Postal Code
54290
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905054785576
Facility Name
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905052292035
Facility Name
Cherkasy Regional Oncology Dispensary ( Site 0959)
City
Cherkasy
State/Province
Cherkaska Oblast
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Suspended
Facility Name
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)
City
Dnipropetrovsk
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Regional Oncology Center of Kharkiv ( Site 0958)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61000
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+380508266088
Facility Name
Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61037
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61166
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
City
Antonivka Village
State/Province
Khersonska Oblast
ZIP/Postal Code
73000
Country
Ukraine
Individual Site Status
Suspended
Facility Name
National Cancer Institute of the MoH of Ukraine ( Site 0962)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Lviv Regional Clinical Hospital ( Site 0955)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79000
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Lviv State Regional Oncological Center ( Site 0967)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79031
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Zhytomyr Regional Oncology Center ( Site 0971)
City
Zhytomyr
State/Province
Zhytomyrska Oblast
ZIP/Postal Code
10002
Country
Ukraine
Individual Site Status
Completed
Facility Name
Kyiv City Clinical Oncology Center ( Site 0960)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kent and Canterbury Hospital ( Site 0733)
City
Canterbury
State/Province
England
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Individual Site Status
Completed
Facility Name
The James Cook University Hospital ( Site 0730)
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441642 850850
Facility Name
Lister Hospital ( Site 0739)
City
Stevenage
State/Province
Hertfordshire
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442078828505
Facility Name
The Royal Marsden Foundation Trust ( Site 0726)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4402078082911
Facility Name
Imperial College Healthcare NHS Trust ( Site 0745)
City
London
State/Province
London, City Of
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442033117627
Facility Name
Western General Hospital ( Site 0749)
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH42XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441315372211
Facility Name
Walsall Manor Hospital-Oncology ( Site 0743)
City
West Midlands
State/Province
Walsall
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Royal Cornwall Hospital ( Site 0727)
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Clatterbridge Oncology Centre ( Site 0731)
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+441513341155
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
34008425
Citation
Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.
Results Reference
derived
Links:
URL
http://merckclinicaltrials.com
Description
Merck Clinical Trials Information
Learn more about this trial
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
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